Is Infliximab safe while breastfeeding?

Effects on the breastfed infant

A retrospective chart review of patients who received infliximab during pregnancy found that 5 mothers breastfed their infants during infliximab therapy at a dose of 5 mg/kg. No other patient details were reported and no adverse effects were reported in the infants, although observation during breastfeeding was not the purpose of the study.[ 24 ] A woman with Crohn's disease received infliximab 5 mg/kg intravenously every 8 weeks throughout pregnancy and during lactation. The infant was reported to be good condition without any evidence of illnesses.[ 25 ] An infant was born to a mother who received infliximab 10 mg/kg 5 times during pregnancy at 6- to 8-week intervals. A maternal dose of 10 mg/kg was given at 2 weeks postpartum. The infant was breastfed for 6 weeks, discontinued for 3 weeks and then reinstated at 9 weeks of age (extent of nursing not stated). Another 10 mg/kg dose was given to the mother at 10 weeks postpartum. The infant underwent a formal evaluation of the immune system and found to have normal immune markers and responses. The infant reportedly grew and developed normally throughout the first year of life.[ 14 ] An infant was breastfed (extent not stated) for up to 4 months by a mother who was taking infliximab (dosage not stated) and azathioprine 150 mg daily for inflammatory bowel diseases. The infant was followed regularly for 22 months of age and found to have a normal growth rate, and no history of recurrent infections.[ 26 ] A woman with severe Crohn's disease received infliximab 1000 mg (10 mg/kg) intravenously every 4 weeks during pregnancy and lactation. The extent and duration of breastfeeding were not reported. The child had no developmental abnormalities noted at 27 months of age.[ 15 ] Three infants were breastfed (extent not stated) during maternal infliximab therapy at a dose of 5 mg/kg every 8 weeks. Infants were followed for almost 1 year and found to have no unusual number or types of infections and all seroconverted after thei

Effects on milk supply

Fifty-seven lactating women, 26 with inflammatory bowel disease (IBD) and 31 without had tumor necrosis factor (TNF) and chemokines (IP-10, MCP-1, and MIP-1 ) measured at 2 to 6 weeks postpartum (early lactation) and again at 11 to 16 weeks (mid-lactation) postpartum. The women with IBD who were receiving either adalimumab (n = 5) or infliximab (n = 4) had lower levels of TNF and Interferon gamma-induced protein 10 (IP-10) in their milk in early lactation sampling than women with IBD who were not taking a TNF inhibitor. No differences were found between either IBD group and women without IBD at either time point nor between any of the groups at mid-lactation.[ 11 ] An analysis of the US Food and Drug Administration s FAERS database of 7,022 spontaneous adverse reaction reports of anti-TNF drugs found that they may cause an increased risk of lactation insufficiency and disorders. Drugs that were studied included adalimumab, infliximab, golimumab, certolizumab, and etanercept. The authors noted that TNF alpha is involved in milk production, adding biological plausibility to the findings.[ 33 ]

Levels in milk

Maternal Levels. A nursing mother with Crohn's disease (time postpartum not stated) was given a single 5 mg/kg dose of infliximab by intravenous infusion. Milk samples taken 24 hours and 1 week after the dose had undetectable ( 60 mcg/L) levels of infliximab.[ 12 ] A woman who was 4 months postpartum received 2 doses of infliximab. Milk levels were measured after the first dose of 160 mg and second dose of 165 mg, but the time between the 2 doses was not stated. The first milk sample was obtained 10 days after the first dose. Milk infliximab levels increased gradually (values not stated) over the next 10 days. After the second dose, milk infliximab levels increased further, with the highest infliximab concentration of 473 mcg/L measured one day after the second dose.[ 13 ] A woman with Crohn's disease received infliximab 10 mg/kg at 2 and 10 weeks postpartum. Infliximab was not detectable in breastmilk with an ELISA assay (assay sensitivity not specified) at 6, 10 or 13 weeks postpartum.[ 14 ] A woman with severe Crohn's disease received infliximab 1000 mg (10 mg/kg) intravenously every 4 weeks during pregnancy and lactation. She received a dose on an unstated day postpartum, then breastmilk samples were collected daily (times not stated) once before and daily for 30 days after the dose. None of the samples had detectable infliximab ( 5 mcg/L) using an ELISA assay.[ 15 ] Three women with Crohn's disease received infliximab during pregnancy and postpartum. Single breastmilk samples were obtained from each woman after a postpartum dose of 5 mg/kg of infliximab. Samples were collected 7, 5, and 43 days, respectively, after their prior dose. Infliximab was undetectable ( 100 mcg/L) in all breastmilk samples.[ 16 ] Three women with Crohn's disease received an intravenous infusion of infliximab 5 mg/kg postpartum for a disease flare and discontinued nursing. Milk samples were obtained before and after the infusion. Milk samples were also obtained from 8 nursing mothers wh

Alternatives LactMed lists

• Etanercept
• Phototherapy
• Certolizumab Pegol
• Etanercept
• Tocilizumab